Transplantation Clinical Trial
Official title:
A Multicenter, Open, Single Sequence Crossover Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Stable Liver Transplant Patients Converted From a Prograf® Based Immunosuppressive Regimen
Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable liver transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.
Multicenter, open, single sequence crossover study. Subject Enrolment: Prograf® administered
twice daily is replaced by Prograf as study medication, administered twice daily.
Six weeks Prograf-Treatment Phase to confirm compliance to regimen stability requirements
(see Inclusion and Exclusion Criteria), and collection of data under Prograf treatment.
Conversion from Prograf (twice daily, morning & evening dosing) total daily dose to MR4 once
daily (only morning dosing) on a 1:1 (mg:mg) basis on Day 1.
Twelve weeks MR4-Treatment Phase with study assessments for safety and efficacy.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00838357 -
A Multi-centre, Open Label, Single-arm Study Intended to Further Investigate the Safety and Efficacy of Plerixafor as a Front-line Mobilisation Agent in Combination With G-CSF in Patients With Lymphoma or MM (Multiple Myeloma).
|
Phase 3 | |
| Terminated |
NCT00778856 -
Hand Transplantation for the Reconstruction of Below the Elbow Amputations
|
N/A | |
| Active, not recruiting |
NCT00166842 -
Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets
|
Phase 4 | |
| Recruiting |
NCT04257747 -
Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI
|
N/A | |
| Completed |
NCT02560909 -
Adjuvanted Influenza Vaccine in Stem Cell Transplant
|
Phase 4 | |
| Active, not recruiting |
NCT01687192 -
Multicenter Trial Evaluating the Immunogenicity of HPV Vaccination in Girls on Immunosuppressive Therapy.
|
Phase 2 | |
| Completed |
NCT00951977 -
Live Kidney Donor Study - Cross-Sectional and Historical Cohort Study
|
N/A | |
| Completed |
NCT00384137 -
A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients
|
Phase 3 | |
| Completed |
NCT00235664 -
Prospective Study of Drug Resistant Pathogens Among Liver, Intestinal and Multivisceral Transplant Recipients
|
N/A | |
| Completed |
NCT03533049 -
mHealth Family Self-Management
|
N/A | |
| Completed |
NCT02826213 -
Comparison of Two Techniques of Renal Pre-transplant Infusion on the Evolution of Renal Function in the Recipient
|
||
| Completed |
NCT00170170 -
Risk Factors for Cytomegalovirus Disease in Solid Organ Transplantation
|
N/A | |
| Recruiting |
NCT06367244 -
Transplant Wellness Program
|
N/A | |
| Recruiting |
NCT06166186 -
Effect of Intraoperative Music on Inflammatory Response in Donor Hepatectomy
|
N/A | |
| Recruiting |
NCT00493194 -
Fibrosis in Renal Allografts
|
Phase 4 | |
| Completed |
NCT00297310 -
Pre-transplant Assessment of Tacrolimus Blood Level Concentration, as a Predictor of Tacrolimus Dose Requirements After Kidney Transplantation
|
Phase 4 | |
| Completed |
NCT01019811 -
Innervated Sensory Cross-Finger Flap
|
N/A | |
| Completed |
NCT04376775 -
Assessment of the Impact of COVID-19 on Transplant Patients and on Patients Awaiting Transplantation
|
||
| Active, not recruiting |
NCT00166816 -
The Pharmacokinetics of Sirolimus When Combined With Cyclosporine or Tacrolimus in Renal Transplant Patients
|
Phase 4 | |
| Recruiting |
NCT03920735 -
Retrospective Non-interventional Analysis of Opportunistic Infections in Immunocompromised and Frail Patients
|